FDA Approves 35th Biosimilar – Alymsys

The FDA approved the 35th biosimilar last week, Alymsys (bevacizumab-maly) from Amneal Pharmaceuticals, for seven cancer indications of the reference product, Avastin from Genentech. It is an infused therapy, so specialty pharmacies won’t have much contact with Alymsys.

Alymsys joins two previously approved biosimilars to Avastin. Myvasi (Amgen, approved in 2017) and Zirabev (Pfizer, approved in 2019).

Patent concerns?
Patent battles were in full bore for years but Avastin did not have the dozens of patents to block competitor approvals as seen in other biosim cases. With the final patent issues resolved, doors are now open for the three biosimilars. Inroads into market share were slow on the uptake but are gaining share rapidly as competition will further gain payer preferences.

Follow the Money
Is all the wait worth it? In short, yes….. especially for Amneal which did not have to spend a mountain of cash on legal challenges. These biosimilars are being sold outside the US and are generating revenues for the biosim manufacturers.

Avastin isn’t the most expensive therapy in the cancer toolbox, but it isn’t cheap either at about $4,000 per cycle. Depending on cancer type and other clinical variables, a patient may receive as few as six cycles or as many as 22. By the way….. Avastin is still among the top selling drugs on the market. Nuff said….

FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly

April 13, 2022 — Amneal said the product, to be sold under the name Alymsys.
It is the second of 3 biosimilars the company expects earn approval in the US this year.

Amneal Pharmaceuticals Wednesday said the FDA approved the company’s Biologics License Application (BLA) for bevacizumab-maly, a biosimilar referencing the originator product (Avastin).

Amneal said the product will be sold under the name Alymsys. It is the third bevacizumab biosimilar approved in the United States.

Earlier this year, Amneal received approval of filgrastim-ayow (Releuko) which references Neupogen. The firm’s pegfilgrastim biosimilar referencing Neulasta is currently under FDA review.

Bevacizumab-maly was developed by mAbxience. The vascular endothelial growth factor inhibitor is indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen
First-line non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel
Recurrent glioblastoma in adults
Metastatic renal cell carcinoma in combination with interferon alfa
Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan
Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel

Avastin, made by Roche, brought in $7 billion for the company in 2018, according to Forbes.


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